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ITM Isotope Technologies Begins Phase III Radionuclide Study in Patients With GEP-NETs

NEW YORK – ITM Isotope Technologies Munich on Tuesday said the first patient with a somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumor (GEP-NETs) has received treatment within the randomized Phase III COMPOSE trial of its radiopharmaceutical ITM-11 (n.c.a. 177Lu-edotreotide).

ITM-11 comprises no-carrier-added radioisotope lutetium-177 fused with the somatostatin analogue edotreotide and is designed to target somatostatin receptor-positive GEP-NETs. In the COMPOSE trial, ITM aims to enroll around 200 patients with well-differentiated high-grade 2/3 GEP-NETs and compare the activity of ITM-11 against the best standard of care, which can be chemotherapy containing capecitabine and temozolomide, or FOLFOX chemotherapy, or everolimus (Novartis' Afinitor).

The primary outcome is progression-free survival. Researchers will also track patients' overall survival in the two arms for up to two years after disease progression.

GEP-NETs are rare cancers that occur in the pancreas or other areas of the gastrointestinal tract. Patients must have confirmed somatostatin receptor-positive disease to partake in COMPOSE, which is being sponsored by ITM Solucin, a subsidiary of ITM Isotope Technologies Munich. The companies are also comparing the radionuclide against everolimus in patients with grade 1/2, inoperable, progressive, somatostatin receptor-positive GEP-NETs in the Phase III COMPETE trial.